https://scholars.lib.ntu.edu.tw/handle/123456789/537630
標題: | Long-term effects of crizotinib in ALK-positive tumors (excluding NSCLC): A phase 1b open-label study | 作者: | Gambacorti-Passerini C. Orlov S. Zhang L. Braiteh F. Huang H. Esaki T. Horibe K. Ahn J.-S. Beck J.T. Edenfield W.J. Shi Y. Taylor M. Tamura K. Van Tine B.A. SHANG-JU WU Paolini J. Selaru P. Kim T.M. |
公開日期: | 2018 | 出版社: | Wiley-Liss Inc. | 卷: | 93 | 期: | 5 | 起(迄)頁: | 607-614 | 來源出版物: | American Journal of Hematology | 摘要: | Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), MET, and ROS1, is approved for treatment of patients with ALK-positive or ROS1-positive advanced non-small-cell lung cancer (NSCLC). However, ALK rearrangements are also implicated in other malignancies, including anaplastic large-cell lymphoma and inflammatory myofibroblastic tumors (IMTs). In this ongoing, multicenter, single-arm, open-label phase 1b study (PROFILE 1013; NCT01121588), patients with ALK-positive advanced malignancies other than NSCLC were to receive a starting dose of crizotinib 250 mg twice daily. Primary endpoints were safety and objective responses based on Response Evaluation Criteria in Solid Tumors version 1.1 or National Cancer Institute International Response Criteria. Forty-four patients were enrolled (lymphoma, n = 18; IMT, n = 9; other tumors, n = 17). The objective response rate was 53% (95% confidence interval [CI], 28–77) for lymphoma, with 8 complete responses (CRs) and 1 partial response (PR); 67% (95% CI, 30–93) for IMTs, with 1 CR and 5 PRs; and 12% (95% CI, 2–36) for other tumors, with 2 PRs in patients affected by colon carcinoma and medullary thyroid cancer, respectively. The median duration of treatment was almost 3 years for patients with lymphoma and IMTs, with 2-year progression-free survival of 63% and 67%, respectively. The most common treatment-related adverse events were diarrhea (45.5%) and vision disorders (45.5%), mostly grade 1. These findings indicate strong and durable activity of crizotinib in ALK-positive lymphomas and IMTs. The safety profile was consistent with the known safety profile of crizotinib even with long-term treatment. ? 2018 The Authors American Journal of Hematology Published by Wiley Periodicals, Inc. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85041656752&doi=10.1002%2fajh.25043&partnerID=40&md5=a60c3b00cc7fb8228a9f49ae8a3b5aae https://scholars.lib.ntu.edu.tw/handle/123456789/537630 |
ISSN: | 0361-8609 | DOI: | 10.1002/ajh.25043 | SDG/關鍵字: | anaplastic lymphoma kinase; creatine kinase; crizotinib; anaplastic lymphoma kinase; crizotinib; abdominal pain; adolescent; adult; advanced cancer; aged; anaplastic large cell lymphoma; Article; brain infarction; cancer survival; clinical article; colon carcinoma; constipation; controlled study; creatine kinase blood level; deep vein thrombosis; diarrhea; disease severity; drug effect; drug response; drug safety; edema; fatigue; female; headache; heart failure; heart muscle ischemia; human; interstitial lung disease; leukopenia; lymphoma; male; middle aged; multicenter study; multiple cycle treatment; National Cancer Institute International Response Criteria; nausea; neutropenia; phase 1 clinical trial; plasma cell granuloma; priority journal; progression free survival; response evaluation criteria in solid tumors; side effect; thyroid medullary carcinoma; treatment duration; visual disorder; vomiting; young adult; antagonists and inhibitors; clinical trial; complication; genetics; lung tumor; mutation; neoplasm; non small cell lung cancer; treatment outcome; Adolescent; Adult; Aged; Anaplastic Lymphoma Kinase; Carcinoma, Non-Small-Cell Lung; Crizotinib; Female; Humans; Lung Neoplasms; Male; Middle Aged; Mutation; Neoplasms; Treatment Outcome; Young Adult |
顯示於: | 醫學系 |
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